Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

• ClinicalTrials.gov Identifier: NCT01931826
• Recruitment Status: Completed
• First Posted: August 29, 2013
• Last Update Posted: August 29, 2013
• Sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
• Information provided by (Responsible Party): Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas

Tracking Information

• First Submitted Date: March 15, 2013
• First Posted Date: August 29, 2013
• Last Update Posted Date: August 29, 2013
• Study Start Date: January 2003
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2013)

Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up. [ Time Frame: 24 months ]

Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by EGDS.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: August 26, 2013): Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up. [ Time Frame: 24 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: August 26, 2013): No other outcomes were evaluated. [ Time Frame: 24 months ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
• Official Title: Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
• Brief Summary: Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account the endemic nature of schistosomiasis mansoni in our region and the high morbidity and mortality directly associated with rupture of esophageal varices and UGIB in affected patients, we conducted a prospective randomized trial in patients with schistosomiasis and a history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by a surgical treatment: Esophagogastric devascularization with splenectomy (EGDS).

Detailed Description

This was a prospective, randomized, single-center study carried out at the Department of Clinical and Surgical Gastroenterology of Hospital Universitário Professor Alberto Antunes, Universidade Federal de Alagoas (HU/UFAL). It was approved by the local Research Ethics Committee (protocol #98/0039-3, code 4010000-6) and all patients provided written informed consent prior to study enrollment. Patients who met relative criteria for exclusion received the current standard of care and follow-up and were analyzed as a third group in the study.

Over a two-year period, 79 patients were recruited for elective treatment of SPH. The criteria for selection were: a) an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension; b) a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding; and c) age between 15 and 65 years.

The exclusion criteria were: chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women; evidence of decompensated liver disease of mixed etiology or of any chronic disease that contraindicated surgery were considered absolute exclusion criteria; the relative criteria for exclusion were altered hemostasis (platelet count < 50×109/L or INR > 1.5); presence of fundal varices on endoscopy.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Schistosomiasis Mansoni
• Portal Hypertension
• Upper Gastrointestinal Bleeding

Intervention

• Procedure: Endoscopic treatment
  The presence of gastroesophageal varices was confirmed by fiberoptic esophagogastroduodenoscopy (EGD). In view of the experience of our service and local circumstances at the time of the study, the endoscopic treatment of choice was sclerotherapy, performed with a Teflon-sheathed metal needle. The sclerosing agent was 2.5% monoethanolamine oleate. Esophageal varices visible on EGD in the pre- and post-treatment period were classified as small, medium or large on the basis of criteria proposed by Paquet. All complications attributable to sclerotherapy were recorded.
• Procedure: Total EGDS+ endoscopy
  Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.

Study Arms

• Active Comparator: Endoscopic treatment alone
  3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
  Intervention: Procedure: Endoscopic treatment
• Active Comparator: Total EGDS + endoscopy
  Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
  Interventions:

  • Procedure: Endoscopic treatment
  • Procedure: Total EGDS+ endoscopy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 26, 2013): 54
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age between 15 and 65 years;
• an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension;
• a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding.

Exclusion Criteria:

• Chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women;
• evidence of decompensated liver disease of mixed etiology or of any chronic disease that contraindicated surgery were considered absolute exclusion criteria;
• the relative criteria for exclusion were altered hemostasis (platelet count < 50×109/L or INR > 1.5);
• presence of fundal varices on endoscopy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01931826
• Other Study ID Numbers: UNCISAL-2012-Treatment PHS
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas
• Study Sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
• Collaborators: Not Provided

Investigators

• Principal Investigator: Celina Lacet, Doctor; Universidade Estadual de Ciências da Saúde de Alagoas

• PRS Account: Universidade Estadual de Ciências da Saúde de Alagoas
• Verification Date: August 2013